Remotely Adjustable Tissue Displacement Device

ABSTRACT

The invention relates to an apparatus for displacing tissue within the body, wherein the apparatus includes two or more attachment members selectively displaceable with respect to each other via a driving member. The driving member preferably is rotatable and is caused to rotate by a magnetic actuator that can be activated by a magnetic field from outside the body.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application Ser.No. 60/790,589 filed on Apr. 6, 2006, entitled “REMOTELY ADJUSTABLEEXPANDABLE DEVICE” and U.S. Provisional Application Ser. No. 60/866,739filed on Nov. 11, 2006, entitled “REMOTELY ADJUSTABLE BONE DISPLACEMENTDEVICE”, both of which are hereby incorporated in their entirety byreference.

TECHNICAL FIELD OF THE INVENTION

The invention generally relates to a device for displacing tissue withina body, such as one or more bones of an animal. More specifically, theinvention relates to implants within a patient that can be remotelyadjusted from outside the body to extend and/or contract.

BACKGROUND OF THE INVENTION

Expandable implants such as the system commercially available bySynthes, Inc. under the trademark VEPTR® (Vertically ExpandableProsthetic Titanium Rib) system are used to displace bones within apatient. For example, small children with heavy spinothoracicdeformities often use such implants attached to the ribs, spine and/orpelvis. The implant is adjusted, usually at regular intervals such asevery 6 months, through small skin incisions. However, the adjustmentoften requires general anesthesia and hospital stay to recover from theadjustment procedure, and also introduces a risk of infection.

SUMMARY OF THE INVENTION

Generally speaking, a device for moving tissue, such as an implant fordisplacing bone is provided. The device can include two elongatedmembers displaceable, preferably telescopically displaceable, withrespect to each other to extend and contract relative to the length ofthe device. A drive member can rotate to extend and/or contract thedevice, and is preferably rotated by a magnetic actuator. The magneticactuator is preferably rotatable by an external magnetic field. Morespecifically, a magnetic field outside the patient's body can beutilized to extend and/or contract the implant within the patient'sbody.

One embodiment of the device includes two elongated members having aproximal end and a distal end, a drive member operably associated withand rotatable relative to one of the elongated members. A magneticactuator assembly may be provided which is associated with the drivemember in such a way that when the magnetic actuator is rotated, thedrive member is also rotated, which causes the two elongated members tomove relative to each other. The magnetic actuator assembly ispreferably rotatable by an external magnetic field.

Another embodiment of the device comprises two bone attachment membersand a displacement mechanism configured for subcutaneous implantation ina position accessible by a magnetic field transmitted through the skin.The device includes a driven member and a rotatable driving membercoupled between the bone attachment members, a lip coupled to thedriving member, a magnet rotatable back and forth in oppositedirections, and a drive tooth coupled to the magnet to contact, tap orimpact against the lip upon back and forth rotation of the magnet.

An alternate embodiment of the device comprises a bone displacementapparatus having two bone attachment members, a driven member coupled toone of the bone attachment members, and a rotatable driving membercoupled to the second bone attachment member. Preferably, the drivingmember and the driven member are associated via screw threads to movethe driven member axially relative to the second bone attachment member.Therefore, upon rotation of the driving member in a displacementdirection, the bone attachment members can be displaced. The device mayalso include a rotatable actuator and a clutch mechanism operativebetween the actuator and the driving member, such that upon rotation ofthe actuator back and forth in opposite directions, the driving memberis advanced in the displacement direction. Preferably, a rotatablemagnet is provided, wherein the rotation of the magnet results in theactuator rotating back and forth.

In accordance with a preferred embodiment of the device, a changingmagnetic field of a magnetic rotor may be used to rotate the drivemember, rather than direct actual magnetic force. For example, the drivemember or actuator for rotating the drive member may oscillate and relyupon impact momentum for such a rotation.

The device may comprise the features of construction, combination ofelements, and arrangement of parts which will be exemplified in theconstruction hereinafter set forth, but the scope of the inventionshould not be limited to such features, combination of elements orarrangement of parts.

The invention accordingly comprises the several elements and therelation of one or more of such elements with respect to each of theothers, and the apparatus embodying features of construction,combination(s) of elements and arrangement of parts which are adapted toeffect such steps, all as exemplified in the following detaileddisclosure, and the scope of the invention will be indicated in theclaims.

BRIEF DESCRIPTION OF THE INVENTION

The device is explained in even greater detail in the followingexemplary drawings. The drawings are merely exemplary to illustrate thestructure of preferred devices and certain features that may be usedsingularly or in combination with other features. The invention shouldnot be limited to the embodiments shown.

FIG. 1 is a front elevational view of an embodiment of a device;

FIG. 2A is a front elevational view of an embodiment of a driveassembly;

FIG. 2B is a front elevational view of an embodiment of a driveassembly;

FIG. 3 is a perspective view of an embodiment of an activator and adevice;

FIG. 4A is a perspective view of an embodiment of an actuator;

FIG. 4B is an exploded perspective view of an embodiment of an actuator;

FIG. 5A is a schematic view of an embodiment of an activator and amagnet;

FIG. 5B is a schematic view of an embodiment of an activator and amagnet;

FIG. 5C is a schematic view of an embodiment of an activator and amagnet;

FIG. 5D is a schematic view of an embodiment of an activator and amagnet;

FIG. 6A is a schematic view of an embodiment of an actuator and adriving member;

FIG. 6B is a schematic view of an embodiment of an actuator and adriving member;

FIG. 6C is a schematic view of an embodiment of an actuator and adriving member;

FIG. 7 is a perspective view of an embodiment of an actuator and adriving member;

FIG. 8 is s perspective view of an embodiment of a device;

FIG. 9 is a perspective view of a section of an embodiment of a device;

FIG. 10 is a side elevational view of an embodiment of a clutchmechanism and an actuator;

FIG. 11 is a perspective view of an embodiment of a clutch mechanism;

FIG. 12A is a side elevational view of the clutch mechanism and theactuator of FIG. 10 in a first position;

FIG. 12B is a side elevational view of the clutch mechanism and theactuator of FIG. 10 in a second position;

FIG. 12C is a side elevational view of the clutch mechanism and theactuator of FIG. 10 in a third position;

FIG. 12D is a side elevational view of the clutch mechanism and theactuator of FIG. 10 in a fourth position;

FIG. 12E is a side elevational view of the clutch mechanism and theactuator of FIG. 10 in a fifth position;

FIG. 12F is a side elevational view of the clutch mechanism and theactuator of FIG. 10 in a sixth position;

FIG. 12G is a side elevational view of the clutch mechanism and theactuator of FIG. 10 in a seventh position;

FIG. 12H is a side elevational view of the clutch mechanism and theactuator of FIG. 10 in a eighth position;

FIG. 12I is a side elevational view of the clutch mechanism and theactuator of FIG. 10 in a ninth position;

FIG. 13 is a side elevational view of an embodiment of a clutchmechanism;

FIG. 14 is a side elevational view of an embodiment of an actuator;

FIG. 15 is a side elevational view of an embodiment of a clutchmechanism and an actuator;

FIG. 16 is a front elevational view of an embodiment of a device;

FIG. 17 is a perspective view of an embodiment of a device;

FIG. 18 is a perspective view of a portion of an embodiment of a device;

FIG. 19A is a top planar view of an embodiment of a device;

FIG. 19B is a cross-sectional view of the device of FIG. 19A taken alonglines 19B-19B;

FIG. 19C is a top view of a section of the device of FIG. 19A;

FIG. 20 is a cross-sectional view of a section of the device of FIG. 19Ataken along lines 20-20.

FIG. 21 is a front elevational view of an embodiment of a device;

FIG. 22 is a front elevational view of a section of the device of FIG.21;

FIG. 23 is a top planar view of an embodiment of a device;

FIG. 24 is a top planar view of a section of the device of FIG. 24;

FIG. 25A is a front elevational view of an embodiment of a device;

FIG. 25B is a cross-sectional view of a section of the device of FIG.25A taken along line 25B-25B;

FIG. 26 is a perspective view of an embodiment of a device;

FIG. 27 is a front elevational view of the device of FIG. 26;

FIG. 28 is a perspective view of a section of the device of FIG. 26.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Certain exemplary embodiments of the invention will now be describedwith reference to the drawings. In general, such embodiments relate to adevice for displacing tissue within the body of an animal, by way ofnon-limiting example, a person with spinothoracic deformity. A childwith spinothoracic deformity often requires an implant periodicallyadjusted to expand the ribcage to permit organs to freely growthereunder without being crowded. Accordingly, it is desirable toprovide a device in accordance with an embodiment of the invention whichprovides remote adjustment of such an implant. Remote adjustment refersto the ability to adjust the device without having to undergo surgery orother invasive or non-invasive procedure.

Reference is made generally to FIGS. 1-3 and 8-9, wherein certainexemplary embodiments of a device for displacing tissue are shown.Device for displacing tissue 100, 500 can be substantially straight,curved, or have another shape in accordance with design choice. In theembodiment shown, device 100, 500 may include a first member 120, 520having a rod 122, 522, which is preferably relatively smooth, and asecond member 140, 540 having a tubular member 142, 542. Rod 122, 522and tubular member 142, 542 are selectively displaceable with respect toeach other, preferably telescopically or laterally displaceable. Firstmember 120, 520 and second member 140, 540 are preferably elongated andmay relatively straight or curved. Furthermore, it is to be understoodthat whereas certain embodiments are described herein as having a drivemember associated with a tubular member, the drive member may beassociated with a rod and vice versa.

In accordance with a preferred embodiment, device 100, 500 includes adrive assembly 200, 600 which displaces first member 120, 520 fromsecond member 140, 540 to extend and/or retract device 100, 500.Preferably, tubular member 142, 542 includes an inner cavity 146, 546within which rod 122, 522 can be received.

In the embodiments shown, first member 120, 520 includes a firstattaching device 124, 524 for attaching to a tissue within the body.Likewise, second member 140, 540 includes a second attaching device 144,544 for attaching to a tissue within the body. The first and secondattaching devices may be hooks, clamps, closed rings or other mechanismsthat can attach to bone, for example, ribs. Examples of suitable clampsare described in U.S. Pat. No. 6,126,664 for “DEVICE AND METHOD FORLOCATING AND RESECTING BONE;” U.S. Pat. No. 6,143,031 for“INTERVERTEBRAL IMPLANT WITH COMPRESSIBLE SHAPED HOLLOW ELEMENT;” U.S.Pat. No. 5,092,889 for “EXPANDABLE VERTICAL PROSTHETIC RIB;” U.S. Pat.No. 5,030,235 for “PROSTHETIC FIRST RIB;” and U.S. Pat. No. 5,261,908for “EXPANDABLE VERTICAL PROSTHETIC RIB.”

As device 100, 500 is extended, first member 120, 520 may be displacedfrom second member 140, 540 and the respective tissues are pushed awayfrom each other. For example, if first member 120, 520 is attached to arib and second attaching device 140, 540 is attached to the hip, the ribbone can be pushed outward to correct or treat a spinothoracicdeformity.

Reference will be made to the embodiment shown in FIGS, 1-3, wherein adrive assembly 200 having a drive member 210 is shown. As shown, drivemember 210 comprises an outer perimeter 214 preferably having at least aportion that is threaded 216, and preferably is attached to rod 122 offirst member 120. As drive member 210 rotates, the threads 216 on theouter perimeter 214 may contact inner cavity 146, inner cavity 146preferably having a threaded portion 148, and drive member 210 movesrelative to the length of tubular member 142. Simultaneously, firstmember 120, which is attached to drive member 210, is also movedrelative to the length of second member 140, preferably within secondmember 140, more preferably telescopically. Furthermore, the threads 216of outer perimeter 214 of drive member 210 and the threaded portion 148of inner cavity 146 of second member 210 cooperate to prevent slippageand retain first member 120 and second member 140 in position. Whereasdrive member 210 is shown as being attached to an end of rod 122, it isto be understood that drive member 210 can be attached to rod 122 atanother location relative to the length of rod 122. It is to beunderstood that the term “rotation” encompasses a partial rotation lessthan 360°, a complete rotation of 360° or greater.

Drive member 210 can be rotated by an actuator 300 for example as shownin FIGS. 4A,B. Actuator 300 preferably includes a magnetic member,preferably a magnet 310, and which is preferably activated by anexternal magnetic activator 400. The embodiment of the actuator 300illustrated is aligned with, preferably concentric with, drive member210, and includes a magnet 310, preferably a cylindrical magnet having afirst pole 312 and a second pole 314, and a ring 320 preferably attachedto magnet 310 such that the rotation of magnet 310 causes ring 320 torotate. An alternate embodiment of the actuator may be arranged parallelto, preferably offset from the drive member.

By way of non-limiting example, first pole 312 can be a north pole andsecond pole 314 can be a south pole. As magnet 310 rotates, drive member210 is rotated, preferably in predetermined increments, thus extendingor retracting device 100 in predetermined increments. Magnet 310 can berotated by a magnetic field external to the body, thus eliminating theneed for an incision or invasive procedure to extend or retract device100. By providing a remotely adjustable device, the patient can be savedfrom the surgical procedures otherwise necessary, and the risk ofinfection and hospitalization associated therewith. Additionally, thealigned, preferably concentric, arrangement of actuator 300 and drivemember 210 can provide a substantially narrow device having a lowprofile, which may reduce patient discomfort and cause less tissueirritation.

An embodiment of external activator 400 is illustrated in FIGS. 3, 5A-Dand preferably includes a face 440 having two or more, preferably fourmagnets 420 a, 420 b having a single pole each mounted on face 440. Asshown in FIG. 3, external activator 400 is preferably located above skinS. In the embodiment shown, external activator 400 includes two magnets420 a having a north pole and two magnets 420 b having a south pole. Thenorth poled magnets 420 a and the south poled magnets 420 b are arrangedin an alternating order. As face 440 is rotated about an axis X by anactivator bar 460, a magnetic field can be created. Referring to FIGS.5A-D, the arrangement of single pole magnets 420 a,b can provide thedesired rotation of magnet 310 as external activator 400 is rotated. Asthe single pole magnets 420 a,b move toward or away from actuator 300,magnets 420 a,b create an attraction (solid arrows) and/or a rejectionforce (dashed lines) with magnet 310 to rotate magnet 310.

Preferably, magnet 310 is attached to a ring 320 having a ring rod 326extending through the center of magnet 310 and a ring tab 322 asillustrated in FIG. 4B. Ring 320 preferably comprises a durablematerial, such as a hard metal, more preferably a material that is notmagnetic and thus unaffected by the external activator 400. Likewise, itis preferably for drive member 210 not to be magnetic. Ring 320 andmagnet 310 can be attached, preferably permanently attached, forexample, using an adhesive, a groove and projection, etc. Ring 320 canalso include a projection 324 extending away from magnet 310 about whichdrive member 210 can rotate.

Referring to the embodiment of actuator 300 shown in FIGS. 5-7, whenmagnet 310 is rotated by external activator 400, ring 320 also rotatesand ring tab 322 contacts and pushes a tooth 212 of drive member 210 torotate drive member 210. The actuator 300 may provide continuousrotation of drive member 210 with the continued rotation of magnet 310to provide a smooth, continuous displacement of rod 120. Alternatively,drive member 210 may be rotated in increments of varying force oroscillate to obtain the necessary torque to rotate drive member 210 asdescribed in more detail below.

In accordance with one embodiment of the device, actuator 300 can extenddevice 100 by rotating drive member 210 in one direction and retractdevice 100 when rotating in the opposite direction. Alternatively,actuator 300 can rotate drive member 210 in one direction to extenddevice 100 without permitting retraction. Other options for therelationship between actuator and drive assembly 200 are also available.

Drive member 210 preferably can be rotated if the static torque, namelythe rotational force of actuator 300 as magnet 310 rotates, is greaterthan the work torque, namely the rotational force required to rotatedrive member 210. Various factors may affect the work torque, such asthe load on the implant, the thread pitch, the friction, etc. The statictorque can be dependent on various factors, such as, by way ofnon-limiting example, the distance between actuator 300 and externalactivator 400, and the magnet material properties. Therefore, the statictorque may be predetermined during manufacture. Once the work torquebecomes greater than the static torque, actuator 300 does not rotatedrive member 210 and magnet 310 ceases to rotate, preferably with ringtab 322 proximate tooth 212. Magnet 310 can then rotate in the oppositedirection such that ring tab 322 rotates away from tooth 212, preferablyabout 180°. Preferably, magnet 310 ceasing to rotate and subsequentlyrotating in the opposite direction occurs relatively quickly, morepreferably such that magnet 310 appears to bounce back upon ring tab 322contacting tooth 212. Meanwhile, activator 400 preferably continues torotate in a consistent direction without oscillating. The degree ofrotation of magnet 310 away from tooth 212 may be determined, forexample, by the number of poles on the magnet 310 or actuator 300.Therefore, ring tab 322 can be accelerated over a rotary angle of 180°,thus creating a greater static torque. Various factors may affect thestatic torque, such as the magnetic material, the mass, the diameter,the activator velocity, and the like. Such an effect may be referred toas a “sledge hammer” effect due to the repeated impacting of therotating ring tab 322. Such a relationship is illustrated in FIGS. 6A-C,wherein ring tab 322 retracts further and further away from tooth 322 tocreate a greater rotary angle and thus a greater static torque.Therefore the torque applied on drive member 210 may be substantiallygreater than the direct torque applied by the rotating magnet.Preferably, such a static torque is about 2 to 15 times greater, morepreferably about ten times greater than the static torque of a rotatingmagnet 310.

In the embodiment shown in FIG. 2A, actuator 300 includes a magnet 310that may be attached to a ring 320 at one end, and an end piece 330 atthe opposite end that preferably prevents magnet 310 from being movedaway from ring 320. Furthermore, actuator 300 may include an axis, suchas an axle 340 about which magnet 310 and ring 320 can rotate, whichpreferably provides a gap and a relatively low friction coefficientbetween ring 320 and drive member 210 and between magnet 310 and endpiece 330.

Reference will now be made to FIGS. 8-15, wherein certain embodiments ofthe device include first member 520 displaceable relative to the lengthof second member 540 by a drive assembly 600, and further includes anactuator 700 that is adjacent to drive assembly 600. In the embodimentsshown, first member 520 includes a rod 522 having an outer perimeter 526that is at least partially threaded 528 and second member 540 includes atubular member 542 having an inner cavity 546 that is preferablysubstantially smooth. Drive assembly 600 includes a drive member 610preferably having a generally cylindrical shape and an outer perimeter614. Drive member 610 comprises an inner surface 616, at least a part ofwhich is threaded and contacts the outer perimeter 526 of rod 522 offirst member 520, which is also at least partially threaded, thuspermitting drive member 610 to move relative to the length of rod 522.Preferably, drive member 610 is concentrically aligned with rod 522.

Whereas a variety of drive assemblies can be used in accordance with thedevice, one embodiment of a suitable drive assembly 600 is shown inFIGS. 9-13. In the embodiment shown, drive assembly 600 includes aclutch mechanism, for example, a freewheel clutch 620 as shown in FIGS.10-13 having one or more, preferably a plurality of stoppers such asneedles or rollers 630 surrounded by an outer housing 620 which ispreferably aligned with, more preferably concentrically aligned with,drive member 610. As shown, freewheel clutch 620 includes outer housing640 surrounding and preferably concentrically aligned with drive member610. Freewheel clutch 620 has a plurality of needles or rollers 630positioned between outer housing 640 and drive member 610. In theembodiment of freewheel clutch 620 shown, outer housing 640 has innerwalls 626 having an incline such that inner walls 626 include convergingwalls 626 a.

Therefore, when outer housing 640 is rotated in one direction, forexample, in a clockwise direction, needles 630 can move, preferablyroll, until they are wedged between converging walls 626 a and outerperimeter 614 of drive member 610 which stops further movement of therollers 630. When the rollers 630 are wedged and stop moving, arotational force is transferred to the drive member 610, thus rotatingdrive member 610. Freewheel clutch 640 can also include one or moresprings 622 which urge needles 630 toward converging walls 626 a.

On the other hand, if outer housing 640 is rotated in the oppositedirection, namely, in a counter-clockwise direction, needles 630 can bereleased to move, preferably roll, toward diverging walls 626 b of outerhousing 640. The work torque required to rotate drive member 610 in acounter-clockwise direction is preferably greater than the forcenecessary for needles 630 to move or roll around the outer perimeter 614of drive member 610. Therefore needles 630 can roll toward divergingwalls 626 b while drive member 610 remains in place. Accordingly,freewheel clutch 640 may provide a ratcheting effect by providing aclockwise rotation but not a counter-clockwise rotation of drive member610. Whereas FIGS. 10-12 show nine needles 630, it is to be understoodthat the number of needles 630 can be varied as a matter of designchoice and to fit the desired application. By way of non-limitingexample, as shown in FIG. 13, an alternate embodiment of freewheelclutch 620 includes six needles 630. Additionally, whereas rollers 630of freewheel clutch 620 are positioned equidistant from each other, therollers need not be equidistant as illustrated in the embodiment of FIG.13. Moreover, in accordance with the embodiment of the freewheel clutchshown, outer housing 640 may have a partially flattened portion 642which may provide a relatively low profile of device and reducediscomfort and cause less tissue irritation.

An embodiment of drive assembly 600 as shown in FIGS. 10-12 includes alever 650 extending radially outward from freewheel clutch 620 andperipherally fixed thereto, lever 650 having an aperture generallyindicated at 652 having an aperture surface 656. Lever 650 is preferablydisplaced by an actuator 700 comprising a rotating member 730 preferablyhaving a generally cylindrical shape and a bulbous projection 732 thatextends radially outward. By way of non-limiting example, rotatingmember 730 can be an eccentric cam or disc. In accordance with apreferred embodiment of drive assembly 600 and actuator 700, bulbousprojection 732 contacts aperture surface 656 as at least a portion ofrotating member 730 rotates within aperture 656. As bulbous projection732 contacts and moves along aperture surface 656, lever 650 can beselectively displaced.

Preferably, as shown in FIG. 9, actuator 700 can include a magnet 710,preferably a cylindrical magnet, which can be rotated by an externalmagnetic field. In the embodiment shown, actuator 700 includes anon-magnetic, hard metal ring 720 having a ring tab 722. For example,actuator 700 can be similar to actuator 300 of FIG. 3 described above,wherein a ring tab 722 can contact a rotating member 730 to forcerotation of rotating member 730 about an actuator rod 750. In accordancewith one embodiment of actuator 700, ring tab 722 can push bulbousprojection 732 as ring tab 722 rotates. Alternatively, rotating member730 can include a tooth 734 extending toward ring 720, which ring tab722 can contact, resulting in rotating member 730 rotating. Such arelationship is described in detail above. Both embodiments can providethe “sledge hammer” effect. Alternatively, rotating member 730 can berotated by magnet 710 directly, thus maintaining the same torque as therotating magnet 710. Additionally, actuator 700 can include a reductiongear, for example, a gear train such that a plurality of rotations ofmagnet 710 can result in a single rotation of a gear at a greatertorque. It is to be understood that other embodiments of the actuatorare within the scope of the invention as a matter of design choice.

An example of the way in which freewheel clutch 620 works is illustratedin FIGS. 12A-I, wherein the sequential relationship between driveassembly 600 and rotating member 730 is illustrated in positions (1)-(9)as rotating member 730 is rotated in a clockwise direction. In position(1), bulbous projection 732 contacts the aperture surface 656 of lever650. As rotating member 730 rotates, bulbous projection 732 moves alongaperture surface 656 in a clockwise direction and pushes lever 650 indirection A, thus rotating outer housing 640 in a clockwise direction asshown in subsequent positions (2) and (3). In the embodiment shown, theclockwise rotation of outer housing 640 results in the rotation of drivemember 610 in the clockwise direction as indicated by the arrows 645.

Preferably, as outer housing 640 rotates in a clockwise direction,needles 630 are stopped by converging inner walls 626 a of outer housing640 until needles 630 are wedged between converging walls 626 a andouter perimeter 614 of drive member 610. A clockwise torque ispreferably generated, for example, by a frictional force evoked by thewedged needles 630. Therefore, the greater the torque generated, themore needles 630 may become wedged, thus increasing the frictional forcebetween outer perimeter 614 of drive member 610 and needles 630 andsubstantially preventing needles 630 from sliding or rolling along outerperimeter 614 of drive member 610. Therefore, as outer housing 640continues to rotate, drive member 610 can be rotated in a clockwisedirection. Position (3) shows drive assembly 600 when lever 650 isdisplaced the maximum distance in direction A. Once this position (3) ispassed, bulbous projection 732 enters a clearance 646 in aperture 652 inposition (4) such that as rotating bulbous projection 732 continues torotate in a clockwise direction, lever 650 is not displaced.

As rotating member 730 continues to rotate in the clockwise direction,bulbous projection 732 moves along aperture surface 656 of lever 650 asshown in position (5) and displaces lever 650 in direction B until lever650 is displaced the maximum distance in direction B as shown inposition (6). As lever 650 is displaced in direction B, outer housing640 rotates in a counter-clockwise direction. By way of non-limitingexample, as outer housing 640 rotates in a counter-clockwise direction,needles 630 are permitted to roll toward diverging walls 626 b of outerhousing 640. Therefore, outer housing 640 can rotate in acounter-clockwise direction without resulting in the rotation of drivemember 610, thus preferably providing a ratcheting effect.

Once the maximum displacement of lever 650 in direction B is reached,bulbous projection 732 preferably enters a clearance 647 in aperture 652such that as rotating bulbous projection 732 continues to rotate in aclockwise direction, lever 650 is not displaced, as shown in positions(7)-(8). In the embodiment shown in FIG. 12, once position (9) isreached, bulbous projection 732 has rotated 360° and has returned toposition (1), and the process can be repeated until the desired rotationof drive member 610 is reached, and thus the desired extension orretraction of device 500. It is to be understood that the magnet mayalso rotate in the other direction.

Accordingly, drive assembly 600 preferably provides a ratcheting effect,by rotating drive member 610 in one direction and not the other, whilelever 650 is displaced back and forth in directions A and B.

Referring to FIG. 14, the coordination of drive assembly 600 andactuator 700 can provide a magnified torque on drive member 610 comparedto the torque of the rotating magnet 710 or rotating element 730. Thesmaller the angle α, the smaller the distance L and greater the forceF1. Therefore, the smaller the initial angle, the less movement of lever650 is generated. Accordingly, bulbous projection 732 preferablycontacts lever 650 at approximately 45°, and the preferred displacementD of lever 650 in direction A is approximately 0.2 mm. This can providea total displacement of lever 650 of about 0.4 mm and a rotation of 2.3°with lever 650 having a length of about 10 mm between a center 718 ofmagnet 710 and a center 628 of freewheel clutch 620. It to be understoodthat the identified dimensions and angles are merely exemplary and notintended to limit the scope of the invention. Rather, the dimensions andangles can be varied as a matter of application specific design choicewithout deviating from the scope of the invention.

In accordance with another embodiment of the drive assembly 660 as shownin FIG. 15, drive assembly 660 can include a drive member 662 having aplurality of teeth 664 and grooves 668 within an outer housing 661,drive member 662 being preferably concentrically aligned with outerhousing 661. Outer housing 661 is preferably associated with a lever 670having a shaft 672 having a projection 674 constructed and arranged tobe selectively received within grooves 668 of drive member 662.

As illustrated in FIG. 15, as lever 670 is displaced in direction A,projection 674 of shaft 672 is received within a groove 668 of drivemember 662 and applies a force in direction A, thus rotating drivemember 662 in a clockwise direction. When lever 670 is displaced indirection B, however, because of the angle of teeth 664 and projection674 of shaft 672, projection 674 of shaft 672 glides across teeth andthus drive member 660 does not rotate in the clock-wise direction, thuscreating a ratcheting effect. The displacement of lever 670 can beactivated by a magnetic actuator, for example, actuator 700 asillustrated in FIG. 9.

Whereas an embodiment of drive assembly 600 having a lever 650 has beenillustrated herein as rotating drive member 610 along rod 522 of firstmember 520, it is to be understood that drive member 610 can be rotatedwithin tubular member 542 of second member 540 without deviating fromthe scope of the invention. Likewise, whereas an embodiment of driveassembly 200 having a magnetic actuator 300 coaxial thereto isillustrated as rotating drive member 210 within the threaded innercavity 146 of tubular member 142, it is to be understood that drivemember 210 can be rotated along rod 122 of first member 120 as a matterof design choice without deviating from the scope of the invention.Alternate embodiments are also contemplated.

Additionally, it may be preferable for drive assembly 600 and actuator700 to be enclosed in a housing to at least substantially prevent tissueirritation during the rotation of the magnet 719 or drive member 610.

Referring to FIGS. 16-20, an embodiment of a device 900 can include afirst member 920 and a second member 940 that are selectivelydisplaceable relative to each other, preferably along the length of oneanother, more preferably telescopically displaceable, by a driveassembly 950 having a drive member 942. First member 920 can include anelongated rod 922 and second member 940 can include an elongated tubularmember 942 within which elongated rod 922 can be telescopicallydisplaced to extend or retract device 900. Alternatively, first member920 and second member 940 can be constructed and arranged such that asdevice 900 extends and contracts, a part of first member 920 moves alongthe side of a part of second member 940, such as for example adjacentrods. Drive member 952 as shown may be fixed, preferably permanently, totubular member 942, wherein drive member 952, and thus tubular member942, can move relative to the length of rod 922.

Preferably, certain embodiments of the device, for example, device 900in FIG. 16, has a curvature, and more preferably has a radius ofcurvature of about 220 mm. Such curvature may be beneficial for use witha spine, for example, within a chest wall. Additionally, device 900 maybe constructed to substantially minimize tissue resistance, for example,when device 900 is being extended. Referring to FIG. 18, tubular member942 may include a relatively sharp edge 944 which preferably cutsthrough the tissue within a patient's body as device 900 is beingextended. Such a sharp edge 944 may be additionally helpful, forexample, when a portion 946 of tubular member 942 projects away from rod922. Whereas portion 946 can be utilized for a variety of functions,portion 946 may be utilized to manually push tubular member 942, orportion 946 can house a lever, actuator, magnet, gears, and the like.

In accordance with a preferred embodiment of rod 922 as shown in FIGS.19A-C, rod 922 includes a generally cross-shaped or (X shape) crosssection, four sides 924 a,b, 926 a,b and has at least a partiallythreaded portion 928. As shown, rod 922 can include two threaded sides924 a,b having a first radius of curvature, and two smooth sides 926 a,bhaving a second radius of curvature preferably different from the firstcurvature, wherein threaded sides 924 a,b and smooth sides 926 a,b arealternatingly positioned around the perimeter of rod 922.

Preferably, drive member 952 includes a threaded portion 954 which cancontact threaded sides 924 to move relative to the length of rod 922 aswell as remain in place without slipping. Smooth sides 926 a,bpreferably do not contact drive member 952 and therefore do not createinterference against drive member 952. More preferably, smooth sides 926a,b have a smaller diameter than threaded sides 924 a,b, thusfacilitating not contacting drive member 952.

Additionally, referring to the embodiment shown in FIGS. 16 and 19B,device 900 may have a top 912 a and a bottom 912 b, wherein device 900curves from top 912 a toward bottom 912 b. Threaded sides 914 a,b may beproximate the sides 916 of device 900. Preferably, referring to FIG.19B, threaded sides 924 a,b are not proximate bottom 912 b where thedistance between the threads may decrease, thus creating clumping ofthreads. Furthermore, providing a smaller diameter of smooth sides 926a,b may prevent jamming the bottom of drive member 952. It is to beunderstood that rod 922 may include more or less threaded sides 924 a,bor smooth sides 926 a,b, and the positioning of threaded sides 924 a,band smooth sides 926 a,b on rod 922 may be altered as a matter of designchoice.

Referring to FIGS. 19A and 19C, tubular member 942 may include a slotgenerally indicated at 944 through which rod 922 can be seen andaccessed. This embodiment of device 900 can facilitate manufacture byproviding slot 944 for access by a machine tool while maintaining device900 relatively compact.

FIG. 20 illustrates a cross section of an exemplary embodiment of drivemember 952 positioned along the length of rod 922, the cross sectiontake along line 20-20 of FIG. 19A. Drive member 952 preferably comprisesa generally cylindrical shape and a threaded portion 954 proximate themiddle region of drive member 952, threaded portion 954 constructed andarranged to contact threaded sides 924 of rod 922 preferably withnon-threaded regions proximate both end portions 956. Drive member maybe operably associated with a rotating mechanism, such as a freewheelclutch 958 for rotating drive member 952. Preferably, threaded portion954 is approximately 4 mm long, and end portions 956 of drive member 952do not include threads. There is preferably no interference between endportions 956 and rod 922, which may facilitate the rotation of drivemember 952 along rod 922 having a curvature.

Referring to FIGS. 21-22, a device 1000 can include two or more firstmembers 1020 having rods 1022, two or more second members 1040 havingtubular members 1042, two or more drive members 1110 associated with,preferably fixed to rods 1022 and located within tubular members 1042,and an actuator 1100 having a magnet 1120. Rods 1022 and tubular members1042 may be relatively curved or straight, more preferably straight. Inaccordance with a preferred embodiment, device 1000 may include tworelatively straight first members 1020 positioned at an angle withrespect to each other. Therefore, device 1000 may better fit the body ofthe patient while facilitating manufacture.

In the embodiment shown, magnet 1120 is a rotatable magnet associatedwith rods 1022 such that the rotation of magnet 1120 results in therotation of rods 1022, preferably simultaneously. Actuator 1100 ispreferably associated with rods 1022 via a flexible coupling 1002, suchas a cardan coupling or universal joint. Drive member 1110 can beassociated with, preferably fixed to, rods 1022, such that the rotationof rods 1022 rotates drive members 1110. Magnet 1120 preferably can berotated by an actuator located outside the skin.

In accordance with an embodiment of device 1000, as magnet 1120 rotates,rods 1022 are rotated, thus rotating drive members 1110 located withintubular member 1042. Tubular member 1042 preferably includes an innercavity 1046 having a threaded region 1044. Drive members 1110 preferablyinclude a threaded region 1114 on its outer perimeter 1112, thuscontacting threads 1044 of tubular members 1042 to move drive members1110 relative to the length of tubular members 1042.

Second members 1040 can include an attaching element 1044 to attach totissue in the body of an animal and a tubular member 1042. Therefore, asfirst members 1020 are displaced relative to the length of secondmembers 1040, device 1000 can be extended or retracted accordingly, thusmoving the tissues of the body closer together or further apart. Such anarrangement may facilitate manufacturing device 1000, and can bebeneficial by partially straightening out as device 1000 is extended,especially in patients where a device having a fixed curvature may leadto a too strong kyphosis when fully expanded. Furthermore, driveassembly 1100 preferably remains fixed within the patient's bodyregardless of how much device 1000 is extended or retracted.

In accordance with the embodiment shown in FIG. 22, first members 1020include housings 1024 for enclosing rods 1022. Housings 1024 may includegrooves 1026, preferably running externally along the length of housing1024. Tubular members 1042 may include projections or pins 1046projecting toward housings 1024. Pins 1046 are preferably constructedand arranged to be received within groove 1026 to substantially preventthe rotation of tubular member 1042 with respect to housing 1024 andvice versa, thus substantially preventing device 1000 from rotatingwithin the patient's body.

FIGS. 23-24 illustrate an embodiment of device 1200 having a firstfreewheel clutch 1210 for two or more rotating rods 1222 in a firstdirection, and a second freewheel clutch 1220 to prevent rods 1222 fromrotating in a second direction opposite to the first direction.Preferably, first freewheel clutch 1210 is associated to a magnet 1230,and second freewheel clutch 1220 is associated with, preferably fixedto, a housing 1240 substantially enclosing second freewheel clutch 1220.A device 1200 as described may be beneficial in situations when eachrotation of first freewheel clutch 1210 is insufficient to transferenough torque to rotate drive members 1260. In such a situation, rods1222 may oscillate back and forth without rotating drive members 1260.Second freewheel clutch 1220 may at least substantially prevent theoscillation of rods 1222 by preventing the reverse rotation of rods1222.

FIGS. 25A-B illustrate another embodiment of device 1050 having twoattaching members 1070, each attaching member 1070 having a rod 1074.Device 1050 may further include one or more connecting members 1060 toconnect the two attaching members 1070 to each other. Attaching members1070 may have an attachment mechanism 1052 for attaching to the tissue,such as a bone, in a body. Referring to FIGS. 25A-B, connecting member1060 may include two tubular members 1062 arranged at an angle less than180 degrees relative to each other, tubular member 1062 constructed andarranged to receive rod 1074. Tubular member 1062 may be connected to adriving member 1066, driving member 1066 preferably rotatable about rod1074, wherein rod 1074 may include a threaded region 1076. Drivingmember 1066 may include a threaded inner perimeter 1068 constructed andarranged to contact threaded region 1076 of rod 1074 to displaceattaching member 1070 relative to connecting member 1060.

Referring to the embodiment of FIGS. 25A-B, connecting member 1060 mayinclude an actuator, for example, a rotatable magnet 1064 connected to acontact member 1065. Preferably, contact member 1065 includes a tab 1065a for contacting a tooth 1066 a of driving member 1066. When tab 1065 acontacts tooth 1066 a with sufficient torque, driving member 1066 mayrotate, thus displacing attaching member 1070 relative to connectingmember 1060. Preferably, magnet 1064 can oscillate to provide aratcheting effect on driving member 1066. In the embodiment shown,device 1050 includes two magnets 1064 which are arranged such that acommon activator may be utilized to rotate both magnets 1064 in the samedirection, thus displacing both attaching members 1070 relative toconnecting member 1060.

Attaching member 1070 preferably includes a housing 1072 constructed andarranged to contain rod 1074 and also possibly a portion, if any, oftubular member 1062. Whereas attaching member 1070 is described hereinas including rod 1074 and connecting member 1060 is described herein asincluding tubular member 1062, it is contemplated that attaching member1070 may include tubular member 1062 and connecting member 1060 mayinclude rod 1074.

Reference is now made to FIGS. 26-27, wherein an embodiment of device1300 is illustrated having a first member 1310 having a rod 1312 and asecond member 1320 having a tubular member 1322, further including adrive assembly 1330 associated with rod 1312 for selectively displacingfirst member 1310 with respect to second member 1320. More specifically,drive assembly 1330 may include a magnetic actuator 1332 for activatinga first freewheel clutch 1334 which preferably rotates a shaft 1336which winds a cable 1340 preferably about shaft 1336. In the embodimentshown, cable 1340 is received within a channel 1313 a which runs alongthe length of rod 1312 on a first side 1314 and a channel 1313 b whichruns along the length of rod 1312 on a second side 1315 such that whencable 1340 is being wound about shaft 1336, cable 1340 moves in a firstdirection C in channel 1313 a and in a second direction D, preferablydifferent from first direction C, in channel 1313 b. Whereas FIGS. 26-28illustrated an embodiment of device 1300 wherein first side 1314 isdifferent from second side 1315, it is to be understood that first side1314 and second side 1315 may be the same side as a matter of designchoice. Preferably, a first end 1342 of cable 1340 is connected, morepreferably fixed, to tubular member 1322. Therefore, as first freewheelclutch 1334 is rotated, cable 1340 is wound about shaft 1336 and firstend 1342 of cable 1340 is pulled in direction D, thus displacing tubularmember 1322 in direction D, away from drive assembly 1330 and thusextending device 1300. Drive assembly 1330 may also include a secondfreewheel clutch 1339 connected to shaft 1336 to prevent the reverserotation of shaft 1336.

One embodiment of the actuator may include a gear train. For example, inan actuator having a magnet that rotates a rotating member which in turnrotates the drive member, a gear train can be provided between themagnet and the rotating member, or between the rotating member and thedrive member as a matter of design choice. It is to be understood that agear train may be provided at various portions of the device, such asthe drive assembly.

One preferred embodiment of the device has a length of about 10 to 200mm, more preferably about 20 to 180, most preferably about 30 to 150 mmwhen fully contracted. Additionally, one embodiment of the device has alength of about 20 to 400 mm, more preferably about 30 to 350 mm, mostpreferably about 40 to 300 mm when fully extended. The radius ofcurvature of the device is preferably between about 100 and 300 mm, morepreferably between about 150 and 250 mm, most preferably about 220 mm.However, it is to be understood that the preferred shape, length,curvature, and the like, of the device varies according to the body inwhich the device is to be inserted, preferably implanted.

Additionally, whereas certain embodiments of the driving member aredescribed herein as having external threading, one of ordinary skill inthe art would appreciate that the embodiments of the drive member mayhave internal threading, and vice versa, as a matter of design choice.For example, providing internal threading may provide an increaseddriving force.

Although the present invention and its advantages have been described indetail, it should be understood that various changes, substitutions, andalterations can be made herein without departing from the spirit andscope of the invention as defined by the appended claims. Moreover, thescope of the present application is not intended to be limited to theparticular embodiments of the process, machine, manufacture, compositionof matter, means, methods and steps described in the specification. Asone of ordinary skill in the art will readily appreciate from thedisclosure of the present invention, processes, machines, manufacture,composition of matter, means, methods, or steps, presently existing orlater to be developed that perform substantially the same function orachieve substantially the same result as the corresponding embodimentsdescribed herein may be utilized according to the present invention.

It will be appreciated by those skilled in the art that variousmodifications and alterations of the invention can be made withoutdeparting from the broad scope of the appended claims. Some of thesehave been discussed above and others will be apparent to those skilledin the art.

1. A bone displacement apparatus comprising: a first bone attachmentmember; a second bone attachment member; and a displacement mechanismconfigured for subcutaneous implantation in a position accessible by amagnetic field transmitted through the skin, including rotatable memberoperatively coupled to the first bone attachment member, a lip coupledto the rotatable member, a magnet rotatable back and forth in oppositedirections, and a drive tooth coupled to the magnet, the drive toothconfigured to contact the lip upon back and forth rotation of the magnetwhereby the bone attachment members are displaced from each other. 2.The apparatus of claim 1 wherein the rotatable member is directlyconnected to the first bone attachment member.
 3. The apparatus of claim1 further comprising a clutch mechanism between the first boneattachment member and the rotating member, wherein the clutch mechanismis configured to displace the second attachment member relative to thefirst attachment member.
 4. The apparatus of claim 1 further comprisinga hand held actuator operative to generate and transmit a rotatingmagnetic field to the magnet through the skin.
 5. A bone displacementapparatus comprising: a first bone attachment member; a second boneattachment member having a driving member; a clutch mechanismoperatively associated with the driving member to advance the drivingmember in a displacement direction; and an actuator constructed andarranged to provide motion to the clutch mechanism; wherein the clutchmechanism includes a plurality of rollers; a housing containing therollers and the driving member, the housing having a converging innerwall portion; a first condition wherein upon rotation of the housing ina first direction, the rollers are wedged between the housing and thedriving member, and the driving member rotates in the first direction;and a second condition wherein upon rotation of the housing in a seconddirection different from the first direction, the driving member remainsstationary without rotating.
 6. The apparatus of claim 5, wherein thefirst and second bone attachment members include an attachment mechanismfor attaching to a bone.
 7. The apparatus of claim 5, wherein thedriving member includes screw threads to move the first bone attachmentmember axially relative to the second bone attachment member uponrotation of the driving member in a displacement direction.
 8. Theapparatus of claim 5, wherein the driving member is rotatable in a firstdirection to displace the first attachment member away from the secondattachment member, the apparatus further comprising a second clutchmechanism constructed and arranged to prevent the driving member fromadvancing in a second direction different from the displacementdirection.
 9. The apparatus of claim 5, wherein at least one of the boneattachment devices includes a slot.
 10. The apparatus of claim 5,wherein the actuator includes a magnet that is rotatable by an externalmagnetic field.
 11. The apparatus of claim 5, wherein the actuator isaligned with the driving member.
 12. The apparatus of claim 5, whereinthe actuator includes a gear train.
 13. The apparatus of claim 5,wherein the actuator is adjacent to the driving member.
 14. Theapparatus of claim 5, further comprising a cable having a first endcoupled to a shaft and a second end coupled to the first bone attachmentmember, wherein the shaft is operatively associated with the clutchmechanism, the clutch mechanism being configured to rotate the shaft todisplace the first attachment member from the second attachment member.15. The apparatus of claim 5, further comprising: a lever connected tothe clutch mechanism, the lever having an aperture; and an eccentricdisk positioned within the aperture, wherein rotation of the eccentricdisk displaces the lever, which provides motion to the clutch mechanism.16. The apparatus of claim 5, further comprising two intermediarymembers between the first and second attachment members, wherein theactuator is positioned between the two intermediary members.
 17. Theapparatus of claim 5, further comprising a projection connected to thesecond attachment member and wherein the first attachment memberincludes a groove for receiving the projection.
 18. The apparatus ofclaim 5, further comprising a radius of curvature of about 220-240 mm.19. The apparatus of claim 5, wherein the actuator includes anoscillating member and an oscillating magnet, wherein the oscillatingmagnet rotates back and forth, and wherein the oscillating memberrotates back and forth in response to the back and forth rotation of themagnet.
 20. The apparatus of claim 5, wherein the first bone attachmentmember has a portion having a generally cross-shaped cross-section, theportion including: a threaded portion having a first threaded sideconstructed and arranged to contact the driving member; and a secondside that does not contact the driving member.
 21. The apparatus ofclaim 20, wherein the portion includes two first threaded sides and twosecond sides.
 22. The apparatus of claim 20, wherein the first threadedside has a first length and the second side has a second length lessthan the first length.
 23. The apparatus of claim 20, wherein thedriving member includes a first end portion and a second end portion anda middle portion, wherein the middle portion includes a threaded regionand the end portions do not have threading.
 24. The apparatus of claim5, further comprising a housing having a relatively sharp edgeconfigured to displace tissue as the apparatus expands.
 25. A device fordisplacing tissue, the device comprising: a first attachment memberhaving a first radius of curvature; a second attachment member having asecond radius of curvature, wherein the second attachment memberincludes a first threaded portion; and a driving member having a secondthreaded portion and an unthreaded portion, the threaded portionconstructed and arranged to contact the first threaded portion of thesecond attachment member, the driving member operatively connected tothe first attachment member wherein rotation of the driving memberselectively displaces the first attachment member from the secondattachment member.
 26. The device of claim 25, wherein the secondattachment member includes a rod having a cross-shaped cross sectionhaving two threaded sides constructed and arranged to contact thedriving member, the rod further including two unthreaded sidesconstructed arranged not to contact the driving member.